Catalog Number

041170

Brand Name

Toomey Syringe

Version/Model Number

041170

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KYZ

Product Code Name

SYRINGE, IRRIGATING (NON DENTAL)

Public Device Record Key

793e936a-ff42-4287-9bdf-487271a08773

Public Version Date

September 30, 2020

Public Version Number

1

DI Record Publish Date

September 22, 2020

Package DI Number

10801741049337

Quantity per Package

25

Contains DI Package

00801741049330

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX